NCT02162251

Brief Summary

To investigate the safety and effectiveness about administration of both donepezil hydrochloride and menatine hydrochloride in patients with Alzheimer's Disease in clinical practice.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,482

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 10, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2016

Completed
Last Updated

September 7, 2018

Status Verified

December 1, 2016

Enrollment Period

1.9 years

First QC Date

June 10, 2014

Last Update Submit

September 6, 2018

Conditions

Alzheimer's Desease

Keywords

Alzheimer's Diseasedonepezil hydrochloride

Outcome Measures

Primary Outcomes (1)

  • Investigations on adverse events and adverse drug reactions

    Up to 12 months

Secondary Outcomes (2)

  • Severity of dementia based on the Functional Assessment Staging Test (FAST)

    Baseline, Month 3, Month 6, and Month 12

  • Change From Baseline in the Mini-Mental State Examination (MMSE) Score

    Baseline and Month 12

Study Arms (1)

E2020

Drug: Donepezil Hydrochloride

Interventions

Donepezil HydrochlorideDRUG

Initial dose of 3 mg orally once daily. After 1-2 weeks, dosage increased to 5 mg orally once daily. After 4 or more weeks, dosage increased to 10 mg orally once daily for patients with severe dementia of Alzheimer's type. Dose reduced appropriately according to patient's symptoms.

Also known as: Aricept
E2020

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Alzheimer's Disease

You may qualify if:

  • Patients diagnosed with Alzheimer's Disease who are to be administered both donepezil hydrochloride and memantine hydrochloride in clinical practice.

You may not qualify if:

  • Patients with a history of hypersensitivity to any ingredients of Aricept or piperidine derivatives.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Multiple Locations, Japan

Location

Related Publications (2)

  • Geriatric Medicine 55(1): 87-100, 2017.

    RESULT

  • Geriatric Medicine 55(11): 1251-1264, 2017.

    RESULT

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Donepezil

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

IndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic Compounds

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2014

First Posted

June 12, 2014

Study Start

June 1, 2013

Primary Completion

May 1, 2015

Study Completion

April 15, 2016

Last Updated

September 7, 2018

Record last verified: 2016-12

Locations

JP(1)